Device product
Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
Z-1718-2015
Product summary
- Event
- Event 71058
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 units
- Official record key
device-enforcement:Z-1718-2015
Official wording
Reason: Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs
Code information: Serial Numbers: 005, 006, 011, 017, 019, 0701101, 07071003, 07071004, 08031005, 08081006, 08091007, 09061009, 09091010, 09101011, 09101012, 10021014, 10031015, 10091017, 10121019, 11051020, 11061021, 11071022, 11091023, 12011026, 12081028, 13021028, 12091029, 12091030, 12121032, 13011033, 13101034, 13071037, 13031035, 14011038, 14041036 and 14061038
Distribution pattern: Worldwide Distribution - US including CA, FL, NJ, TX, WA, Internationally: Korea, Russia, Kuwait, Canada, Greece, Lebanon, Turkey, Egypt, Saudi Arabia, China, Armenia, Azerbaijan, Australia.
Derived failure modes
-
Unknown
Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs